• New patient-reported outcomes data shows improved function and reduced symptom burden with HERNEXEOS® (zongertinib tablets) as an initial treatment option in HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC)¹
• Data for HERNEXEOS monotherapy and in combination in other HER2-altered solid tumors, including breast, colorectal and esophageal cancers, shows encouraging early signals^2-4
• Updated data adds to the growing evidence base of obrixtamig in extensive‑stage small cell lung cancer (ES‑SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC)^5-6

RIDGEFIELD, Conn. and INGELHEIM, Germany, May 21, 2026 /PRNewswire/ -- At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, Boehringer Ingelheim will present new data from across its robust oncology clinical development program. Key data includes patient-reported outcomes with HERNEXEOS® (zongertinib tablets) as an initial orally administered treatment option for HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) and early results evaluating HERNEXEOS in other types of cancer driven by HER2 alterations. Updated data for obrixtamig, an investigational DLL3/CD3-targeting T-cell engager, will also be presented in extensive-stage small cell lung cancer (ES-SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC). 

"In the past year, Boehringer has meaningfully advanced the NSCLC treatment landscape through multiple regulatory approvals of zongertinib across markets. These new patient-reported outcomes for zongertinib further add to the growing body of evidence characterizing its clinical profile," said Itziar Canamasas, Ph.D., Global Head of Oncology at Boehringer Ingelheim. "Building on this progress, our ambition is to advance precision cancer care across tumor types and modalities by exploring zongertinib's potential in other HER2-driven cancers, as well as next-generation approaches such as T-cell engagers. At ASCO, these data reflect our commitment to understanding what truly matters to patients, as we continue to shape an innovative oncology portfolio designed to deliver meaningful, unprecedented impact for people facing cancer." 

Showcasing patient-reported outcomes for HERNEXEOS® in HER2-mutant NSCLC
New patient-reported outcomes (N=71) from the Phase Ib Beamion LUNG-1 trial (NCT04886804) showed improvements within one week of treatment in patients' physical functioning with HERNEXEOS as an initial treatment for adult patients with HER2 (ERBB2)-mutant advanced NSCLC, building on the efficacy and safety data that supported the recent U.S. FDA accelerated approval.¹ Results showed:

• Patients reported improvements in physical functioning and NSCLC‑related symptoms from baseline, which were sustained over time (as measured by EORTC QLQ-C30 and NSCLC-SAQ total score).¹
• Patient-reported symptomatic adverse events (AEs) as assessed by PRO-CTCAE were in line with HERNEXEOS's published safety data.¹
• HERNEXEOS was well tolerated, as reflected by the low overall side effect burden (as assessed by EORTC IL46/Q168) and the mild nature for most patient-reported symptomatic AEs (based on PRO-CTCAE measures).¹ 

"For people living with HER2-mutant advanced NSCLC, it's especially important to understand how treatment affects how they feel and function in daily life," said Dr. Joshua K. Sabari, study investigator and Associate Professor, Department of Medicine, New York University (NYU) Grossman School of Medicine; Medical Director, Thoracic Medical Oncology, NYU Langone Health's Perlmutter Cancer Center. "These patient-reported outcomes showed that the patients who received treatment with zongertinib reported improvements in physical functioning and symptom burden. These findings build on previous clinical data to further support the use of zongertinib in the first-line setting for adult patients with HER2-mutant advanced NSCLC." 

Advancing research with HERNEXEOS® data in HER2-positive colorectal, esophageal and breast cancers
Early data to be presented highlights the potential of HERNEXEOS in other HER2-driven cancers, including metastatic colorectal cancer (mCRC), metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC) and metastatic breast cancer (mBC). These data will inform continued clinical development across multiple tumor types.

• A pooled analysis of patients (N=19) with HER2-positive mCRC from the Phase Ia Beamion LUNG-1 trial (NCT04886804) and the Phase II Beamion PANTUMOR-1 trial (NCT06581432) demonstrated early clinical activity and a manageable safety profile with HERNEXEOS as a monotherapy. The confirmed objective response rate (ORR) was 42% (n=8; all partial responses) and the disease control rate was 95%. The most common treatment-related AEs were diarrhea (n=9), rash (n=3), anemia (n=2), and increased AST (n=2), dysgeusia (n=2) and paronychia (n=2). No grade 4 or 5 AEs were reported.²
• Data from Beamion BCGC-1 (NCT06324357), an ongoing Phase Ib/II multicohort trial, showed evidence of clinical activity for HERNEXEOS as a monotherapy and in combination with other agents.^3,4
  • In patients with HER2-positive mGEAC (n=16) who had disease progression following prior trastuzumab-based therapy, confirmed responses with HERNEXEOS in combination with trastuzumab deruxtecan were observed; 10 patients had a confirmed response (1 complete response and 9 partial responses), 5 patients had stable disease responses and 1 patient had progressive disease.³ HERNEXEOS-related AEs were reported in 85.7% of patients (n=18); the most common treatment-emergent AEs were diarrhea (n=12), nausea (n=10), and anemia (n=5). No grade 4 or 5 AEs were reported and no new safety signals were observed.³
  • Encouraging clinical activity was observed in heavily pretreated patients with HER2-positive mBC treated with HERNEXEOS in combination with trastuzumab emtansine (Cohort A) and trastuzumab deruxtecan (Cohort B).⁴ In Cohort A, of the 13 response-evaluable patients, 3 had partial responses and 9 had stable disease. In Cohort B, of the 15 response-evaluable patients, 4 had partial responses and 11 patients had stable disease.⁴ No new safety signals were observed with HERNEXEOS in combination with other medicines.⁴ In Cohort A (n=16), HERNEXEOS-related AEs were reported in 87.5% of patients (n=14); the most common treatment-emergent AEs were increased AST (n=6), increased ALT (n=5), and decreased platelet count (n=5).⁴ In Cohort B (n=16), HERNEXEOS-related AEs were reported in all patients; the most common treatment-emergent AEs were diarrhea (n=10), nausea (n=10), and anemia (n=7).⁴

These initial findings highlight the potential of HERNEXEOS beyond lung cancer and support its continued research and development across multiple HER2-driven cancers. 

Exploring DLL3-directed therapy with obrixtamig in ES-SCLC
Updated efficacy and safety results will also be presented from the ongoing Phase I DAREON®‑8 trial with obrixtamig, an investigational DLL3/CD3 T-cell engager, in combination with standard-of-care induction therapy (carboplatin, etoposide and atezolizumab) followed by maintenance obrixtamig plus atezolizumab in the first-line treatment of ES-SCLC (N=44), demonstrating encouraging efficacy.⁵

• The confirmed ORR was 73%, with 7% of patients achieving a complete response and 66% achieving a partial response, and the disease control rate was 91%. In the 60 mg cohort (n=29), the confirmed ORR was 76% (10% complete response, 66% partial response).⁵
• Median duration of response (mDoR) and median progression‑free survival (PFS) were not yet reached, with 6‑ and 9‑month PFS rates of 78% and 62%, respectively.⁵
• Overall, the safety profile of the combination was generally consistent with the known profiles of the individual agents, with grade ≥3 AEs primarily related to chemotherapy. Cytokine release syndrome was the most common obrixtamig-related AE (57%).⁵
• Discontinuations due to obrixtamig‑related AEs were infrequent (n=1).⁵

"Given the longstanding need for innovative treatment options in small cell lung cancer, DLL3‑directed approaches such as obrixtamig represent an important area of ongoing research," said Dr. Solange Peters, Professor and Director of Oncology, University Hospital of Lausanne, Switzerland. "In a disease where delivery of later lines of treatment is often not feasible and where urgent disease control is critical, these findings support continued investigation of obrixtamig in combination with standard-of-care therapy as initial treatment of extensive-stage small cell lung cancer." 

Presentations at ASCO 2026 from Boehringer Ingelheim's diverse oncology pipeline reflect its ambition to reshape cancer care: 

About HERNEXEOS^® (zongertinib tablets) 

HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that inhibits HER2 (ERBB2).^7,8 HERNEXEOS has been approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer.⁷

Comprehensive biomarker testing using next generation sequencing determines a patient's eligibility for treatment with HERNEXEOS by identifying HER2 (ERBB2)-mutant advanced NSCLC.^7,9

The treatment is being evaluated in ongoing trials, across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating HERNEXEOS as a first-line treatment for patients with advanced NSCLC that have HER2 tyrosine kinase domain mutations (NCT06151574).¹⁰ Beamion LUNG-3 is a Phase III clinical trial investigating HERNEXEOS as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).¹¹

About obrixtamig 

Obrixtamig is an investigational novel Immunoglobin G (IgG)-like bispecific T-cell engager designed to bind concomitantly to DLL3 on tumor cells and CD3 on T-cells, potentially resulting in destruction of tumor cells by the body's own immune system.¹² Obrixtamig is being evaluated in multiple, ongoing clinical trials, including a Phase I trial in combination with atezolizumab and chemotherapy in extensive-stage small-cell lung cancer (ES-SCLC) patients (DAREON®-8), a Phase Ib study in combination with topotecan in patients with advanced SCLC (DAREON®-9), and a Phase II trial in patients with relapsed/refractory DLL3-high extrapulmonary neuroendocrine carcinomas (epNEC) (DAREON®-5).^5,13,14 Obrixtamig in combination with atezolizumab plus standard-of-care (SOC) chemotherapy is being evaluated as a first-line treatment vs. atezolizumab plus SOC chemotherapy in a Phase III trial for patients with ES-SCLC (DAREON®-LUNG-1).¹⁵ Additionally, a Phase III trial is ongoing to evaluate obrixtamig in combination with SOC chemotherapy vs. chemotherapy alone as first-line treatment in patients with DLL3-positive unresectable locally advanced or metastatic epNEC (DAREON®-NEC-1).¹⁶

About Boehringer Ingelheim in oncology 

We have a clear aspiration – to transform the lives of people facing cancer by delivering unprecedented impact, with the ultimate goal to redefine standards of care. Boehringer Ingelheim's long-term commitment to scientific innovation is reflected by the company's robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as in smart combinations of these approaches. In everything we do, we focus on people — not just data — working alongside them to develop solutions that truly meet their needs and help move cancer into the background of their lives. This drives our research approach, drawing on diverse minds and a long-term perspective to address the needs of people facing cancer today and for generations to come. Read more at https://www.boehringer-ingelheim.com/us/human-health/cancer.

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at https://www.boehringer-ingelheim.com/us. 

What is HERNEXEOS (zongertinib tablets)?

HERNEXEOS is a prescription medicine used to treat adults with a type of lung cancer called non–squamous non–small cell lung cancer (NSCLC) that:

• cannot be removed by surgery or that has spread to other parts of your body (metastatic), and
• has a certain mutation in the human epidermal growth factor receptor 2 (HER2) gene

Your healthcare provider will perform a test to make sure HERNEXEOS is right for you.

It is not known if HERNEXEOS is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Before taking HERNEXEOS, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have heart problems
• have lung or breathing problems other than lung cancer
• are pregnant or plan to become pregnant. HERNEXEOS can harm your unborn baby

Females who are able to become pregnant:

• • Your healthcare provider will do a pregnancy test before you start treatment with HERNEXEOS
  • Use an effective form of birth control (contraception) during treatment with HERNEXEOS and for 2 weeks after your last dose
  • Talk to your healthcare provider about birth control methods that might be right for you during this time
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with HERNEXEOS

• are breastfeeding or plan to breastfeed. It is not known if HERNEXEOS passes into your breastmilk. Do not breastfeed during treatment and for 2 weeks after your last dose of HERNEXEOS

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HERNEXEOS may affect the way other medicines work, and other medicines may affect how HERNEXEOS works.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

What are the possible side effects of HERNEXEOS?
HERNEXEOS may cause serious side effects, including:

• liver problems. Liver problems are common with HERNEXEOS and can be severe and life-threatening. Your healthcare provider will do blood tests to check your liver function before you start taking HERNEXEOS and during your treatment. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:

• • yellowing of your skin or the white part of your eyes (jaundice)
  • dark or brown (tea colored) urine
  • pain on the upper right side of your stomach area (abdomen)
  • bleeding or bruising more easily than normal
  • feeling very tired
  • loss of appetite
  • nausea or vomiting

• heart problems that may affect your heart's ability to pump blood. HERNEXEOS can cause severe heart problems. Your healthcare provider will do tests to check your heart function before you start taking HERNEXEOS and during treatment. Tell your healthcare provider right away if you have any new or worsening symptoms of heart problems, including:

• • feeling like your heart is pounding or racing
  • dizziness
  • tiredness
  • feeling lightheaded
  • shortness of breath
  • loss of consciousness
  • coughing
  • swelling of your legs, ankles, or feet

• lung problems. HERNEXEOS can cause lung problems that are severe or life-threatening. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever

Your healthcare provider may temporarily stop, decrease your dose, or permanently stop treatment with HERNEXEOS if you have serious side effects.

The most common side effects of HERNEXEOS include:

• diarrhea. HERNEXEOS can cause severe diarrhea. Tell your healthcare provider right away if you have new or worsening diarrhea
• rash
• liver problems
• feeling tired
• nausea
• muscle and joint pain
• upper respiratory tract infection

The most common severe abnormal blood tests include decreased white blood cell count, increased liver function tests, and decreased potassium levels.

HERNEXEOS may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of HERNEXEOS. Call your doctor for medical advice about side effects. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CL-HER-100001 02.2026

References
¹ Sabari, JK, et al. PRO results from the Beamion LUNG-1 trial in treatment-naïve patients with HER2-mutant advanced NSCLC. Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 – June 2, 2026; Chicago, IL.
² Arnold, D, et al. Zongertinib in HER2-altered colorectal cancer: a pooled analysis of colorectal cancer patients from two clinical trials . Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 – June 2, 2026; Chicago, IL.
³ Nakayama, I, et al. Zongertinib combined with T-DXd in HER2-positive metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC): first results from a Phase Ib/II dose-escalation trial . Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 – June 2, 2026; Chicago, IL.
⁴ Kitano, S, et al. Zongertinib combination therapy in HER2-positive metastatic breast cancer (mBC): first results from a phase Ib/II trial. Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 – June 2, 2026; Chicago, IL.
⁵ Peters, S, et al. DAREON®-8: updated efficacy and safety from a phase I dose-escalation/expansion trial of first-line (1L) obrixtamig plus chemotherapy and atezolizumab in extensive-stage small cell lung carcinoma (ES-SCLC). Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 – June 2, 2026; Chicago, IL.
⁶ Gambardella, V. et al. Analysis of delta-like ligand 3 (DLL3) expression levels and characteristics of patients (pts) with advanced extrapulmonary neuroendocrine carcinomas (epNECs) from an ongoing phase I trial. Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 – June 2, 2026; Chicago, IL.
⁷ HERNEXEOS Prescribing Information.
⁸ Wilding B, Woelflingseder L, Baum A, et al. Zongertinib (BI 1810631), an Irreversible HER2 TKI, Spares EGFR Signaling and Improves Therapeutic Response in Preclinical Models and Patients with HER2-Driven Cancers. Cancer Discov. 2025;15(1):119-138. doi:10.1158/2159-8290.CD-24-0306
⁹ Zeng J, Ma W, Young RB, Li T. Targeting HER2 genomic alterations in non-small cell lung cancer. J Natl Cancer Cent. 2021;1(2):58-73.
¹⁰ ClinicalTrials.gov. Beamion LUNG-2 (NCT06151574). Accessed May 2026.
¹¹ ClinicalTrials.gov. Beamion LUNG-3 (NCT07195695). Accessed May 2026.
¹² Horn L, Mansfield AS, Szczęsna A, Havel L, Krzakowski M, Hochmair MJ, et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med. 2018;379(23):2220–2229. doi:10.1056/NEJMoa1809064
¹³ ClinicalTrials.gov. DAREON-9 (NCT05990738). Accessed May 2026.
¹⁴ ClinicalTrials.gov. DAREON-5 (NCT05882058). Accessed May 2026.
¹⁵ ClinicalTrials.gov. DAREON-Lung-1 (NCT07472517). Accessed May 2026.
¹⁶ ClinicalTrials.gov. DAREON-NEC-1 (NCT07544654). Accessed May 2026. 

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